Atrial Flutter, Ventricular Tachycardia
Conditions
Keywords
atrial flutter, AVNRT, right sided accessory pathway, ventricular tachycardia, Patients who have one or more standard indications for a right-sided diagnostic electrophysiology procedure.
Brief summary
The purpose of this clinical study is to collect safety and performance data to support a demonstration of substantial equivalence of the Catheter Robotics Remote Catheter System to predicate devices when used to perform EP mapping of the right heart (atrium and ventricle).
Interventions
DEVICEAmigo catheter robot
The Amigo Catheter System is intended to facilitate manipulation, positioning and control of a Diagnostic Catheter.
Sponsors
Medpace, Inc.
Catheter Robotics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \> 18years of age. 2. Indicated for a right-sided electrophysiology ablation study (e.g., atrial flutter, AVNRT, right-sided accessory pathway, or ventricular tachycardia). 3. Willingness, ability, and commitment to participate in the procedure visit and a follow-up evaluation including a clinic visit at 7 (-0, +7) days after the study procedure. 4. Completion of Informed Consent.
Exclusion criteria
1. Any contraindication to cardiac catheterization, including pregnancy. 2. Enrollment in any other ongoing cardiac device trial. 3. Right-sided cardiac prosthetics including implanted active energy devices with permanent leads in or through the right atrium and/or ventricle. 4. Corrected or uncorrected atrial septal defect (ASD). 5. Poor general health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e., other disease processes, mental capacity, etc.). 6. Medical condition that will require anticoagulation during study or ablation procedure. 7. Presence of atrial fibrillation or atrial flutter at time of study procedure. 8. Other condition observed prior to the procedure where, in the view of the physician, participation in the study could further present a risk to the subject. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Navigation Performance | During Procedure | Effectiveness Navigation Performance -- The ability to navigate the mapping catheter under Amigo control to at least 80% of 8 pre-specified anatomical locations over all subjects. |
| Evaluation of Major Complications | Seven Days (visit 3), except for any subject with an ongoing SAE that is related to the study will be scheduled for additional evaluations at 14 day intervals. | Safety Evaluation of Major Complications definitely or probably related to Amigo-Controlled Mapping through Visit 3 follow-up. |
Countries
United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intent-to-Treat Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS. | 181 |
| Total | 181 |
Baseline characteristics
| Characteristic | Intent-to-Treat |
|---|---|
| Age Continuous | 56.6 years STANDARD_DEVIATION 16.4 |
| Region of Enrollment United Kingdom | 29 participants |
| Region of Enrollment United States | 152 participants |
| Sex: Female, Male Female | 100 Participants |
| Sex: Female, Male Male | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 181 |
| serious Total, serious adverse events | 0 / 181 |
Outcome results
Primary
Evaluation of Major Complications
Safety Evaluation of Major Complications definitely or probably related to Amigo-Controlled Mapping through Visit 3 follow-up.
Time frame: Seven Days (visit 3), except for any subject with an ongoing SAE that is related to the study will be scheduled for additional evaluations at 14 day intervals.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent-to-Treat | Evaluation of Major Complications | 0 Participants |
Primary
Navigation Performance
Effectiveness Navigation Performance -- The ability to navigate the mapping catheter under Amigo control to at least 80% of 8 pre-specified anatomical locations over all subjects.
Time frame: During Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent-to-Treat | Navigation Performance | 1396 Successful locations |